Medicament delivery device having an electronic circuit system

ABSTRACT

Medicament delivery devices are described herein. In some embodiments, an apparatus includes a medical injector and an electronic circuit system. The medical injector includes a housing, a medicament container, and a medicament delivery member. The housing defines a first region and a second region. The first region includes the medicament container and is physically isolated from the second region. The electronic circuit system is configured to be disposed within the second region defined by the housing. The electronic circuit system is configured to output an electronic output associated with a use of the medical injector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/550,893, entitled “Medicament Delivery Device Having an ElectronicCircuit System,” filed Jul. 17, 2012, which is a continuation of U.S.patent application Ser. No. 12/119,016, now U.S. Pat. No. 8,231,573,entitled “Medicament Delivery Device Having an Electronic CircuitSystem,” filed May 12, 2008, which is a continuation-in-part of U.S.patent application Ser. No. 11/679,331, entitled “Medical InjectorSimulation Device,” filed Feb. 27, 2007, which is a continuation-in-partof U.S. patent application Ser. No. 11/671,025, now U.S. Pat. No.8,172,082, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 5, 2007, which is a continuation-in-part of U.S.patent application Ser. No. 11/621,236, now U.S. Pat. No. 7,731,686,entitled “Devices, Systems and Methods for Medicament Delivery,” filedJan. 9, 2007, which is a continuation-in-part of U.S. patent applicationSer. No. 10/572,148, now U.S. Pat. No. 7,749,194, entitled “Devices,Systems and Methods for Medicament Delivery,” filed Mar. 16, 2006, whichis a national stage filing under 35 U.S.C. §371 of International PatentApplication No. PCT/US2006/003415, entitled “Devices, Systems andMethods for Medicament Delivery,” filed Feb. 1, 2006, which claimspriority to U.S. Provisional Application Ser. No. 60/648,822, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Feb. 1,2005 and U.S. Provisional Application Ser. No. 60/731,886, entitled“Auto-Injector with Feedback,” filed Oct. 31, 2005, each of which isincorporated herein by reference in its entirety. U.S. patentapplications Ser. Nos. 11/621,236, 11/679,331 and 11/671,025 also claimpriority to U.S. Provisional Application Ser. No. 60/787,046, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Mar. 29,2006, which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to a medicament delivery device, and/or a simulatedmedicament delivery device having an electronic circuit system.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

To actuate such a medicament delivery device, however, the user may berequired to execute a series of operations. For example, to actuate someknown auto-injectors, the user must remove a protective cap, remove alocking device, place the auto-injector in a proper position against thebody and then press a button to actuate the auto-injector. Failure tocomplete these operations properly can result in an incomplete injectionand/or injection into an undesired location of the body. In certaininstances, for example, users who have become confused in the operationof some known auto-injectors have inadvertently injected the medicamentinto their thumb by improperly positioning the auto-injector.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, and may therefore have no experience with the medicamentdelivery device. Similarly, because some known medicament deliverydevices are configured to be used relatively infrequently in response toan allergic reaction or the like, even those users familiar with thedevice and/or who have been trained may not be well practiced atoperating the device. Finally, such devices are often used during anemergency situation, during which even experienced and/or trained usersmay be subject to confusion, panic, and/or the physiological effects ofthe condition requiring treatment.

Some known medicament delivery devices include printed instructions toinform the user of the steps required to properly deliver themedicament. Such printed instructions, however, can be inadequate forthe class of users and/or the situations described above. Moreover,because some known medicament delivery devices, such as, for example,auto-injectors, pen injectors, inhalers or the like, can be compact,such printed instructions may be too small to read and comprehend duringan emergency situation.

Some known medicament delivery devices are associated with simulatedmedicament delivery devices (e.g., “trainers”) to provide a method forusers to practice using the medicament delivery device without beingexposed to the medicament and/or needles typically contained therein.Such simulated medicament delivery devices, however, can also includeinadequate use instructions as described above.

Monitoring the patient's compliance with known medicament deliverydevices can also be problematic. For example, some known medicamentdelivery systems include a medicament delivery device and an electronicsystem to assist the user in setting the proper dosage and/ormaintaining a compliance log. Such known medicament delivery systems andthe accompanying electronic systems can be large and therefore notconveniently carried by the user. Such known medicament delivery systemsand the accompanying electronic systems can also be complicated to useand/or expensive to manufacture. Moreover, some known medicamentdelivery systems include sensors disposed within the medicament deliverypath, which can interfere with the delivery, result in contamination, orthe like.

Thus, a need exists for medicament delivery systems and/or devices thatprovide instructions that can be easily understood by a user in any typeof situation. Additionally, a need exists for simulated medicamentdelivery systems and/or devices that can provide instructions and thatcan be reused multiple times. Moreover, a need exists for medicamentdelivery systems and/or devices that can provide compliance informationassociated with the use of the device and/or that can communicateelectronically with other communications devices.

SUMMARY

Medicament delivery devices are described herein. In some embodiments,an apparatus includes a medical injector and an electronic circuitsystem. The medical injector includes a housing, a medicament container,and a medicament delivery member. The housing defines a first region anda second region. The first region includes the medicament container andis physically isolated from the second region. The electronic circuitsystem is configured to be disposed within the second region defined bythe housing. The electronic circuit system is configured to output anelectronic output associated with a use of the medical injector.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIG. 2 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIGS. 3 and 4 are perspective views of a medical injector according toan embodiment of the invention, in a first configuration.

FIG. 5 is a front view of the medical injector illustrated in FIG. 3with the cover removed.

FIG. 6 is a back view of the medical injector illustrated in FIG. 3 withthe cover removed.

FIG. 7 is a front view of a portion of the medical injector illustratedin FIG. 3.

FIG. 8 is a perspective view of a portion of the medical injectorillustrated in FIG. 3.

FIG. 9 is a bottom perspective view of a housing of the medical injectorillustrated in FIG. 3.

FIG. 10 is a top perspective view of a housing of the medical injectorillustrated in FIG. 3.

FIG. 11 is a perspective view of a proximal cap of the medical injectorillustrated in FIG. 3.

FIG. 12 is a front view of a medicament delivery mechanism of themedical injector illustrated in FIG. 3.

FIG. 13 is a back view of an electronic circuit system of the medicalinjector illustrated in FIG. 3.

FIG. 14 is a front view of a portion of the electronic circuit system ofthe medical injector illustrated in FIG. 13.

FIG. 15 is a side view of the electronic circuit system of the medicalinjector illustrated in FIG. 13.

FIG. 16 is a front view of an electronic circuit system housing of themedical injector illustrated in FIG. 13.

FIG. 17 is a perspective view of the electronic circuit system housingof the medical injector illustrated in FIG. 16.

FIG. 18 is a perspective view of a battery clip of the medical injectorillustrated in FIG. 13.

FIG. 19 is a perspective view of a portion of an electronic circuitsystem of the medical injector illustrated in FIG. 3, in a firstconfiguration.

FIG. 20 is a front view of the medical injector illustrated in FIG. 3 ina first configuration showing the electronic circuit system.

FIGS. 21, 22, and 23 are front views of a portion of the electroniccircuit system of the medical injector labeled as Region Z in FIG. 20 ina first configuration, a second configuration, and a thirdconfiguration, respectively.

FIGS. 24 and 25 are perspective views of a cover of the medical injectorillustrated in FIG. 3.

FIG. 26 is a perspective view of a safety lock of the medical injectorillustrated in FIG. 3.

FIG. 27 is a front view of the safety lock of the medical injectorillustrated in FIG. 26.

FIG. 28 is a bottom view of the safety lock of the medical injectorillustrated in FIG. 26.

FIG. 29 is a perspective view of a needle sheath of the safety lock ofthe medical injector illustrated in FIG. 26.

FIG. 30 is a perspective view of a base of the medical injectorillustrated in FIG. 3.

FIG. 31 is a front view of the base of the medical injector illustratedin FIG. 3.

FIG. 32 is a back view of the medical injector illustrated in FIG. 3 ina second configuration.

FIG. 33 is a back view of the medical injector illustrated in FIG. 3 ina third configuration.

FIG. 34 is a back view of the medical injector illustrated in FIG. 3 ina fourth configuration.

FIG. 35 is a perspective view of a housing of a medical injectoraccording to an embodiment of the invention.

FIG. 36 is a perspective view of an electronic circuit system of amedical injector according to an embodiment of the invention.

FIG. 37 is a back view of a printed circuit board of the electroniccircuit system shown in FIG. 36.

FIG. 38 is a schematic illustration of the electronic circuit systemshown in FIG. 36.

FIG. 39 is a perspective cross-sectional view of the housing and theelectronic circuit system illustrated in FIG. 35 and FIG. 36respectively.

FIG. 40 is a cross-sectional perspective view of a portion of theelectronic circuit system illustrated in FIG. 36, taken along line X-Xin FIG. 39.

FIG. 41 is a flow chart illustrating a method of assembling a medicalinjector according to an embodiment of the invention.

FIG. 42 is a flow chart illustrating a method of assembling a simulatedmedical injector according to an embodiment of the invention.

FIG. 43 is a flow chart illustrating a method of testing a medicalinjector according to an embodiment of the invention.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a medical injector and anelectronic circuit system. The medical injector includes a housing, amedicament container, and a medicament delivery member. The housingdefines a first region and a second region. The first region includesthe medicament container and is physically isolated from the secondregion. The electronic circuit system is configured to be disposedwithin the second region defined by the housing. The electronic circuitsystem is configured to output an electronic output associated with ause of the medical injector.

In some embodiments, an apparatus includes a medical injector and anelectronic circuit system. The medical injector includes a housing, amedicament container, and a medicament delivery member. The medicamentdelivery member can be, for example, a needle or an injection nozzle.The housing defines a first region and a second region. The first regionincludes the medicament container and is physically isolated from thesecond region. The electronic circuit system is configured to bedisposed within the second region defined by the housing. The electroniccircuit system includes a printed circuit board having a substrate andan electrical conductor disposed on the substrate. The substrate of theprinted circuit board is configured to receive an actuator configured todisrupt the electrical conductor. The actuator can be, for example, anactuator configured to initiate delivery of a medicament from themedical injector. The electronic circuit system is configured to outputan electronic output associated with a use of the medical injector whenthe electrical conductor is disrupted. In some embodiments, theelectronic output can be, for example, associated with recorded speech.

In some embodiments, an apparatus includes a medicament delivery deviceand an electronic circuit. The medicament delivery device, which can be,for example, a pen injector, an auto-injector, an inhaler or atransdermal delivery device, includes a housing, a medicament container,and a medicament delivery member. The medicament container and at leasta portion of the medicament delivery member are disposed within thehousing. The medicament container and the medicament delivery memberdefine a medicament delivery path. The electronic circuit system iscoupled to the housing and is physically isolated from the medicamentdelivery path. The electronic circuit system is configured to output anelectronic output in response to a delivery of a medicament via themedicament delivery path. In some embodiments, the electronic output canbe, for example, a visual output, an audible output, and/or a hapticoutput.

In some embodiments, an apparatus includes a medical injector having ahousing, a medicament container and a medicament delivery member. Thehousing defines a first region including at least the medicamentcontainer and a second region configured to receive an electroniccircuit system. The first region of the housing is physically isolatedfrom the second region of the housing. The electronic circuit system isconfigured to output an electronic output associated with a use of themedical injector. In some embodiments, the medical injector isconfigured to deliver only a single dose of medicament into a body. Inother embodiments, the medical injector is configured to be reusable.

In some embodiments, an apparatus includes an electronic circuit systemconfigured to be coupled to a medical injector such that, the electroniccircuit system is physically isolated from a medicament delivery path.The electronic circuit system is configured to output an electronicoutput in response to the delivery of a medicament via the medicamentdelivery path. The electronic output can be, for example, a visualoutput, an audible output, and/or a haptic output.

In some embodiments, a method includes assembling a medical deviceconfigured to deliver a medicament into a body of a patient. The medicaldevice includes a housing, a medicament container, an actuator and asafety lock. The medicament container is disposed within the housing.The actuator is configured to initiate delivery of the medicament fromthe medicament container when the actuator is actuated. The safety lockis configured to prevent actuation of the actuator. An electroniccircuit system is coupled to the housing of the assembled medical devicesuch that an opening defined by a substrate of the electronic circuitsystem is disposed about a portion of the safety lock. The electroniccircuit system is configured to output an electronic output in responseto a movement of the safety lock within the opening.

In some embodiments, a method includes coupling an electronic circuitsystem to a simulated medicament delivery device such that a portion ofthe housing actuates a switch of the electronic circuit system. Thesimulated medicament delivery device is configured to simulate an actualmedicament delivery device. The electronic system is configured tooutput an electronic output associated with a use of the simulatedmedicament delivery device and a state of the switch. The electronicoutput can be, for example, a visual output, an audible output, and/or ahaptic output.

In some embodiments, an apparatus includes a simulated medicamentdelivery device and an electronic circuit system. The simulatedmedicament delivery device, which can be, for example, a pen injector,an auto-injector, an inhaler or a transdermal delivery device, isconfigured to simulate an actual medicament delivery device. Thesimulated medicament delivery device includes a housing, a safety lockand a cover. The safety lock is configured to simulate a safety lock ofthe actual medicament delivery device. The cover is removably disposedabout at least a portion of the housing. The electronic circuit systemis configured to output a first plurality of electronic outputs when thecover is removed from the housing a first time. The electronic circuitsystem is configured to output a second plurality of electronic outputswhen the cover is removed from the housing a second time. The secondplurality of electronic outputs are different from the first pluralityof electronic outputs. In some embodiments, the first and/or the secondplurality of electronic outputs can be, for example, visual outputs,audible outputs, and/or haptic outputs.

In some embodiments, a processor-readable medium storing coderepresenting instructions to cause a processor to perform a processincludes code to output a first electronic output associated with a useof a simulated medicament delivery device when a cover is removed fromthe simulated medicament delivery device a first time. Theprocessor-readable medium includes code to output a second electronicoutput associated with a use of the simulated medicament delivery devicewhen the cover is removed a second time. The second electronic output isdifferent from the first electronic output. The simulated medicamentdelivery device can be, for example, a pen injector, an auto-injector,an inhaler or a transdermal delivery device. In some embodiments, thefirst and/or second electronic outputs can be, for example, a visualoutput, an audible output, and/or a haptic output.

As used in this specification and the appended claims, the words“proximal” and “distal” refer to direction closer to and away from,respectively, an operator (e.g., surgeon, physician, nurse, technician,etc.) of the medical device. Thus, for example, the end of themedicament delivery device contacting the patient's body would be thedistal end of the medicament delivery device, while the end opposite thedistal end would be the proximal end of the medicament delivery device.

FIG. 1 is a schematic illustration of a medical injector 1000, accordingto an embodiment of the invention. The medical injector 1000 includes ahousing 1110, a medicament container 1560, a medicament delivery member1512 and an electronic circuit system 1900. The housing 1110 includes asidewall 1148 that defines a first region 1157 and a second region 1153within the housing 1110. More particularly, the sidewall 1148 physicallyisolates the first region 1157 from the second region 1153. Said anotherway, the sidewall 1148 is devoid of openings such that the first region1157 is fluidically and/or physically isolated from the second region1153. Said yet another way, the sidewall 1148 is disposed between thefirst region 1157 and the second region 1153 such that the first region1157 is separated from the second region 1153. Although the first region1157 and the second region 1153 are shown in FIG. 1 as beingtwo-dimensional areas, in some embodiments, the first region 1157 and/orthe second region 1153, can be fully enclosed volumes within thehousing, and/or volumes within the housing 1110 having an opening to anarea outside of the housing. Similarly stated, the first region and/orthe second region can be cavities, defined by the housing 1110 and/orthe sidewall 1148.

The medicament container 1560, which can be, for example, a pre-filledcartridge, a vial, an ampule or the like, is disposed within the firstregion 1157 of the housing 1110. At least a portion of the medicamentdelivery member 1512 is disposed within the first region 1157 of thehousing 1110. In some configurations, the medicament delivery member1512 can be in fluid communication with the medicament container 1560.In this manner, a medicament can be conveyed from the medicamentcontainer 1560 to a region outside the housing 1110 via the medicamentdelivery member 1512. The medicament delivery member 1512 can include,for example, a needle and/or a nozzle.

At least a portion of the electronic circuit system 1900 is disposedwithin the second region 1153 of the housing 1110. Accordingly, theportion of the electronic circuit system 1900 is disposed within thehousing 1110 such that the portion of the electronic circuit system 1900is fluidically and/or physically isolated from the medicament container1560 and/or the medicament delivery member 1512.

The electronic circuit system 1900 is configured to output an electronicoutput OP1 associated with a use of the medical injector 1000. Forexample, in some embodiments, the electronic output OP1 can beassociated with an instruction for using the medical injector 1000. Inother embodiments, the electronic output OP1 can be a post-useinstruction, such as, for example, a recorded message notifying the userthat the injection is complete, instructing the user on post-injectiondisposal and safety procedures, instructing the user to seekpost-injection medical treatment, and/or the like. In yet otherembodiments, the electronic output OP1 can be associated with thepatient's compliance in using medical injector 1000. In someembodiments, the electronic output OP1 can be associated with anactuation of the medical injector 1000. Said another way, the electroniccircuit system 1900 can be configured to output the electronic outputOP1 in response to actuation of the medical injector 1000.

The electronic output OP1 can be, for example, a visual output such as,for example, a text message to display on a screen (not shown), and/oran LED. In some embodiments, the electronic output OP1 can be an audiooutput, such as, for example, recorded speech, a series of tones, and/orthe like. In other embodiments, the electronic output OP1 can be awireless signal configured to be received by a remote device.

The medical injector 1000 can be any suitable medical injector forinjecting medicament into a body of a patient. For example, the medicalinjector 1000 can be a syringe, pen injector, auto-injector or the like.In some embodiments, the medical injector 1000 can be a chronic-careinjector. Said another way, the medical injector 1000 can be a reusabledevice containing multiple doses of medicament. For example, a medicalinjector 1000 having multiple doses of medicament can be used to manageinsulin delivery or the delivery of other medicaments (e.g., to treatMultiple Sclerosis, Anemia, Rheumatoid Arthritis, Osteoporosis or thelike), which can require daily, weekly, and/or monthly injections. Inother embodiments, the medical injector 1000 can be a single-use device.Said another way, the medical injector 1000 can contain a single dose ofmedicament. In some embodiments, medical injector 1000 can include thesame dosage of a medicament, and can be prescribed as a part of achronic-care medicament regimen, clinical trial, or the like. In otherembodiments, medical injector 1000 can include different dosages, and/ordifferent medicament compositions.

The sidewall 1148 can be any suitable structure to isolate the firstregion 1157 within the housing 1110 from the second region 1153 withinthe housing 1110. In some embodiments, the sidewall 1148 can be rigid.In other embodiments, the sidewall 1148 can be a movable member such as,for example, a piston. In yet other embodiments, the sidewall 1148 canbe a flexible member such as, for example, a diaphragm. In someembodiments, the sidewall 1148 can be constructed from a transparentmaterial such that light can pass from the first region 1157 to thesecond region 1153, and vice versa. A transparent sidewall can be usedin conjunction with an optical sensor. The sidewall 1148 can beintegrally formed with the housing 1110 or can be formed separately fromthe housing 1110.

The electronic circuit system 1900 can include any suitable electroniccomponents operatively coupled to produce and/or output the electronicoutput OP1 and/or to perform the functions described herein. Theelectronic circuit system 1900 can be similar to the electronic circuitsystems described in U.S. patent application Ser. No. 11/621,236,entitled “Devices, Systems and Methods for Medicament Delivery,” filedJan. 9, 2007, which is incorporated herein by reference in its entirety.

FIG. 2 is a schematic illustration of a medicament delivery device 2000,according to an embodiment of the invention. The medicament deliverydevice 2000 includes a housing 2110, a medicament container 2560, amedicament delivery member 2512 and an electronic circuit system 2900.The medicament container 2560, which can be, for example, a pre-filledcartridge, a vial, an ampule or the like, is disposed within the housing2110. At least a portion of the medicament delivery member 2512 isdisposed within the housing 2110. The medicament delivery member 2512can include any suitable member configured to convey a medicament fromthe medicament container 2560 to a location within a patient's body. Forexample, in some embodiments, the medicament delivery member 2512 can bea needle, a nozzle, and/or an inhaler mouth piece.

In use, the medicament delivery member 2512 can be in fluidcommunication with the medicament container 2560. In this manner, themedicament delivery member 2512 and the medicament container 2560 candefine a medicament delivery path 2505 through which a medicament 2568can be conveyed from the medicament container 2560 to a location outsidethe housing 2110 via the medicament delivery member 2512 as shown byarrow AA. In some embodiments, the medicament delivery path 2505 caninclude portions of a lumen defined by the medicament delivery member2512 and/or the connection between the medicament delivery member 2512and the medicament container 2560.

The electronic circuit system 2900 is coupled to the housing 2110 and isfluidically and/or physically isolated from the medicament delivery path2505. The electronic circuit system 2900 is configured to output anelectronic output OP2 in response to a delivery of the medicament 2568via the medicament delivery path 2505. In this manner, the electroniccircuit system 2900 can output the electronic output OP2 in anunobtrusive manner and/or without impeding the delivery of themedicament 2568 through the medicament delivery path 2505. In someembodiments, for example, the electronic output OP2 can be a post-useinstruction, such as, for example, a recorded message notifying the userthat the injection is complete, instructing the user on post-injectiondisposal and safety procedures, instructing the user on post-injectionmedical treatment, and/or the like. In other embodiments, the electronicoutput OP2 can be associated with the patient's compliance in using themedicament delivery device 2000. For example, in some embodiments, theelectronic output OP2 can be a signal sent to a compliance trackingmonitor to record the data and/or time of use of the medicament deliverydevice 2000.

The electronic output OP2 can be, for example, a visual output such as,for example, a text message to display on a screen (not shown), and/oran LED. In some embodiments, the electronic output OP2 can be an audiooutput, such as, for example, recorded speech, a series of tones, and/orthe like. In other embodiments, the electronic output OP2 can be awireless signal configured to be received by a remote device.

The medicament delivery device 2000 can be any suitable medicamentdelivery device for delivering the medicament 2568 to a body of apatient. For example, the medicament delivery device 2000 can be asyringe, pen injector, auto-injector, inhaler or the like. In someembodiments, the medicament delivery device 2000 can be a chronic-caredelivery device. Said another way, the medicament delivery device 2000can be a reusable device containing multiple doses of medicament 2568.In other embodiments, the medicament delivery device 2000 can be asingle-use device. Said another way, the medicament delivery device 2000can contain a single dose of medicament 2568.

The electronic circuit system 2900 can include any suitable electroniccomponents operatively coupled to produce and/or output the electronicoutput OP2 and/or to perform the functions described herein. Theelectronic circuit system 1900 can be similar to the electronic circuitsystem 1900 as described above with reference to FIG. 1.

FIGS. 3-34 show a medical injector 4000, according to an embodiment ofthe invention. FIGS. 3-4 are perspective views of the medical injector4000 in a first configuration (i.e., prior to use). The medical injector4000 includes a housing 4110, a delivery mechanism 4500 (see e.g., FIG.12), an electronic circuit system 4900 (see e.g., FIGS. 13-23), a cover4200 (see e.g., FIGS. 24-25), a safety lock 4700 (see e.g., FIGS. 26-29)and a base 4300 (see e.g., FIGS. 30-31). A discussion of the componentsof the medical injector 4000 will be followed by a discussion of theoperation of the medical injector 4000.

As shown in FIGS. 5-11, the housing 4110 has a proximal end portion 4140and a distal end portion 4120. The housing 4110 defines a first statusindicator aperture 4150 and a second status indicator aperture 4151. Thefirst status indicator aperture 4150 defined by the housing 4110 islocated on a first side of the housing 4110, and the second statusindicator aperture 4151 of the housing 4110 is located on a second sideof the housing 4110. The status indicator apertures 4150, 4151 can allowa patient to monitor the status and/or contents of a medicamentcontainer 4560. For example, by visually inspecting the status indicatorapertures 4150, 4151, a patient can determine whether the medicamentcontainer 4560 contains a medicament and/or whether a medicament hasbeen dispensed.

As shown in FIGS. 9 and 10, the housing 4110 defines a gas cavity 4154,a medicament cavity 4157 and an electronic circuit system cavity 4153.The gas cavity 4154 has a proximal end portion 4155 and a distal endportion 4156. The gas cavity 4154 is configured to receive the gascontainer 4570 and the release member 4540 of the medicament deliverymechanism 4500 (see e.g., FIG. 12) as described in further detailherein. The proximal end portion 4155 of the gas cavity 4154 isconfigured to receive the gas container retention member 4580 of theproximal cap 4112 of the housing 4110, as described in further detailherein. The gas cavity 4154 is in fluid communication with themedicament cavity 4157 via a gas passageway 4144, as described infurther detail herein, and the gas cavity 4154 is in fluid communicationwith a region outside the housing 4110 via a safety lock aperture 4128.

The medicament cavity 4157 is configured to receive a portion of thedelivery mechanism 4500. In particular, the carrier 4520, the moveablemember 4530 and the needle 4512 of the medicament delivery mechanism4500 are movably disposed in the medicament cavity 4157. The medicamentcavity 4157 is in fluid communication with a region outside the housing4110 via a needle aperture 4122.

The electronic circuit system cavity 4153 is configured to receive theelectronic circuit system 4900. The housing 4110 has protrusions 4149(see e.g., FIG. 8) configured to stabilize the electronic circuit system4900 when the electronic circuit system 4900 is disposed within theelectronic circuit system cavity 4153. The housing 4110 also definesconnection apertures 4152 configured to receive connection protrusions4171 of the electronic circuit system 4900, and aperture 4145 (see e.g.,FIG. 6) configured to receive a portion of a protrusion 4174 of theelectronic circuit system 4900. In this manner, the electronic circuitsystem 4900 can be coupled to the housing 4110 within the electroniccircuit system cavity 4153. In other embodiments, the electronic circuitsystem 4900 can be coupled within the electronic circuit system cavity4153 by other suitable means such as an adhesive, a clip and/or thelike.

The electronic circuit system cavity 4153 is fluidically and/orphysically isolated from the gas cavity 4154 and/or the medicamentcavity 4157 by a sidewall 4148. The sidewall 4148 can be any suitablestructure to isolate the electronic circuit system cavity 4153 withinthe housing 4110 from the gas cavity 4154 and/or the medicament cavity4157 within the housing 4110. Similarly, the gas cavity 4154 and themedicament cavity 4157 are separated by a sidewall 4146. In someembodiments, sidewall 4146 can be similar to the sidewall 4148, whichisolates the gas cavity 4154 and the medicament cavity 4157 from theelectronic circuit system cavity 4153. In other embodiments the gascavity 4154 can be fluidically and/or physically isolated from themedicament cavity 4157.

The proximal end portion 4140 of the housing 4110 includes a proximalcap 4112, a speaker protrusion 4147 (see e.g., FIGS. 8 and 9), and coverretention protrusions 4142 (see e.g., FIGS. 4 and 6). The speakerprotrusion 4147 is configured to maintain a position of an audio outputdevice 4956 of the electronic circuit system 4900 relative to thehousing 4110 when the electronic circuit system 4900 is attached to thehousing 4110, as described herein. Cover retention protrusions 4142 areconfigured to be received within corresponding openings 4215 on thecover 4200. In this manner, as described in more detail herein, thecover 4200 can be removably coupled to and disposed about at least aportion of the housing 4110.

As shown in FIG. 11, the proximal cap 4112 includes a gas containerretention member 4580 and defines a gas passageway 4144. The gascontainer retention member 4580 is configured to receive and/or retain agas container 4570 that can contain a pressurized gas. The gaspassageway 4144 is configured to allow for the passage of gas containedin the gas container 4570 from the gas cavity 4154 to the medicamentcavity 4157, as further described herein. Said another way, the gaspassageway 4144 places the gas cavity 4154 in fluid communication withthe medicament cavity 4157.

As shown in FIGS. 7 and 9, the distal end portion 4120 of the housing4110 defines a battery isolation protrusion aperture 4121, a needleaperture 4122, a safety lock actuator groove 4123, a safety lockaperture 4128, a base actuator groove 4124, base retention recesses4125A, 4125B, and base rail grooves 4127. The battery isolationprotrusion aperture 4121 is configured to receive the battery isolationprotrusion 4235 of the cover 4200 (see e.g., FIG. 25), as described infurther detail herein.

The needle aperture 4122 is configured to allow the needle 4512 (seee.g., FIG. 12) to exit the housing 4110 when the medical injector 4000is actuated. The portion of the sidewall of the housing 4110 thatdefines the needle aperture 4122 includes multiple sheath retentionprotrusions 4126. In some embodiments, the sheath retention protrusionscan interact with the a plurality of ribs 4728 of the needle sheath 4720(see e.g. FIG. 29) to maintain a position of the needle sheath 4720relative to the safety lock 4700 when the safety lock 4700 is coupled tothe housing 4110 and/or when the safety lock 4700 is being removed fromthe housing 4110.

The safety lock actuator groove 4123 is configured to receive anactuator 4744 of the safety lock 4700. As described in more detailherein, the actuator 4744 is configured to engage and/or activate theelectronic circuit system 4900 when the safety lock 4700 is moved withrespect to the housing 4110. The safety lock aperture 4128 is configuredto receive a safety lock protrusion 4742 (see e.g., FIGS. 25 and 26). Asdescribed in more detail below, the safety lock protrusion 4742 isreceived within an opening 4554 between extensions 4552 of a releasemember 4540 such that activation of the medical injector 4000 isprevented when the safety lock 4700 is in place. The safety lock 4700,its components and functions are further described herein.

The distal base retention recesses 4125A are configured to receive thebase connection knobs 4358 of the base 4300 (see e.g., FIG. 30) when thebase 4300 is in a first position relative to the housing 4110. Theproximal base retention recesses 4125B are configured to receive thebase connection knobs 4358 of the base 4300 when the base 4300 is in asecond position relative to the housing 4110. The base retentionrecesses 4125A, 4125B have a tapered proximal sidewall and a non-tapereddistal sidewall. This allows the base retention recesses 4125A, 4125B toreceive the base connection knobs 4358 such that the base 4300 can moveproximally relative to the housing 4110, but cannot move distallyrelative to the housing 4110. Said another way, the distal baseretention recesses 4125A are configured to prevent the base 4300 frommoving distally when the base 4300 is in a first position and theproximal base retention recesses 4125B are configured to prevent thebase 4300 from moving distally when the base 4300 is in a secondposition. Similarly stated, the proximal base retention recesses 4125Band the base connection knobs 4358 cooperatively prevent “kickback”after the medical injector 4000 is actuated.

The base actuator groove 4124 is configured to receive an actuator 4311of the base 4300. As described in more detail herein, the actuator 4311of the base 4300 is configured to engage the electronic circuit system4900 when the base 4100 is moved with respect to the housing 4110. Thebase rail grooves 4127 are configured to receive the guide members 4312of the base 4300. The guide members 4312 of the base 4300 and the baserail grooves 4127 of the housing 4110 engage each other in a way thatallows the guide members 4312 of the base 4300 to slide in a proximaland/or distal direction within the base rail grooves 4127 while limitinglateral movement of the guide members 4312. This arrangement allows thebase 4300 to move in a proximal and/or distal direction with respect tothe housing 4110 but prevents the base 4300 from moving in a lateraldirection with respect to the housing 4110.

FIG. 12 shows the medicament delivery mechanism 4500 of the medicalinjector 4000. The medical injector 4000 is similar to theauto-injectors described in U.S. patent application Ser. No. 11/562,061,entitled “Devices, Systems and Methods for Medicament Delivery,” filedNov. 21, 2006, which is incorporated herein by reference in itsentirety. Accordingly, only an overview of the medicament deliverymechanism 4500 and related operation of the medical injector 4000 isincluded below.

The medicament delivery mechanism 4500 includes a needle 4512, a carrier4520, a movable member 4530, a medicament container 4560, a gascontainer 4570, and a release member 4540. As described above, theneedle 4512, carrier 4520, movable member 4530 and medicament container4560 are disposed within the medicament cavity 4157 of the housing 4110.The gas container 4570 and the release member 4540 are disposed withinthe gas cavity 4154 of the housing 4110.

The release member 4540 has a proximal end portion 4542 and a distal endportion 4544, and is movably disposed within the distal end portion 4156of the gas cavity 4154. The proximal end portion 4542 of the releasemember 4540 includes a sealing member 4545 and a puncturer 4541. Thesealing member 4545 is configured to engage the sidewall of the housing4110 defining the gas cavity 4154 such that the proximal end portion4155 of the gas cavity 4154 is fluidically isolated from the distal endportion 4156 of the gas cavity 4154. In this manner, when gas isreleased from the gas container 4570, the gas contained in the proximalend portion 4155 of the gas cavity 4154 is unable to enter the distalend portion 4156 of the gas cavity 4154. The puncturer 4541 of theproximal end portion 4542 of the release member 4540 is configured tocontact and puncture a frangible seal 4573 on the gas container 4570when the release member 4540 moves proximally within the gas cavity4154, as shown by the arrow BB in FIG. 12.

The distal end portion 4544 of the release member 4540 includesextensions 4552. The extensions 4552 include projections 4547 thatinclude tapered surfaces 4549 and engagement surfaces 4548. Further, theextensions 4552 define an opening 4554 between the extensions 4552. Thetapered surfaces 4549 of the projections 4547 are configured to contactprotrusions 4313 on a proximal surface 4310 of the base 4300 (see e.g.,FIG. 30). The engagement surfaces 4548 of the projections 4547 areconfigured to extend through the safety lock aperture 4128 of thehousing 4110 and contact a distal surface of the housing 4110. In thismanner, the engagement surfaces 4548 of the projections 4547 limitproximal movement of the release member 4540 when the engagementsurfaces 4548 are in contact with the distal surface of the housing4110.

The opening 4554 defined by the extensions 4552 is configured to receivethe safety lock protrusion 4742 of the safety lock 4700 (see e.g., FIG.27). The safety lock protrusion 4742 is configured to prevent theextensions 4552 from moving closer to each other. Said another way, thesafety lock protrusion 4742 is configured to ensure that the extensions4552 remain apart and the engagement surfaces 4548 of the projections4547 remain in contact with the distal end portion 4120 of the housing4110. In some embodiments, for example, the release member 4540 and/orthe extensions 4552 can be constructed from any suitable materialconfigured to withstand deformation that may occur when exposed to aload over an extended period of time. In some embodiments, for example,the release member 4540 and/or the extensions 4552 can be constructedfrom brass.

The gas container 4570 includes a distal end portion 4572 and a proximalend portion 4576, and is configured to contain a pressurized gas. Thedistal end portion 4572 of the gas container 4570 contains a frangibleseal 4573 configured to break when the puncturer 4541 of the proximalend portion 4542 of the release member 4540 contacts the frangible seal4573. The gas container retention member 4580 of the proximal cap 4112of the housing 4110 is configured to receive and/or retain the proximalend portion 4576 of the gas container 4570. Said another way, theposition of the gas container 4570 within the gas cavity 4154 ismaintained by the gas container retention member 4580.

The medicament container 4560 of the medicament delivery mechanism 4500has a distal end portion 4562 and a proximal end portion 4566, and isconfigured to contain a medicament. The distal end portion 4562 of themedicament container 4560 contains a seal 4523. The seal 4523 isconfigured to burst when punctured by the proximal end 4516 of theneedle 4512, as described below. The proximal end portion 4566 of themedicament container 4560 is configured to receive a piston portion 4534of the movable member 4530.

The movable member 4530 of the medicament delivery mechanism 4500 ismovably disposed within the medicament cavity 4157. The movable member4530 includes a piston portion 4534 having a plunger at the distal endportion of the piston portion 4534. The piston portion 4534 isconfigured to move within the medicament container 4560. In this manner,the piston portion 4534 of the movable member 4530 can apply pressure toa medicament contained in the medicament container 4560. The pistonportion 4534 can be constructed of a resilient, durable, and/or sealingmaterial, such as a rubber.

The carrier 4520 of the medicament delivery mechanism 4500 includes adistal end portion 4522 and a proximal end portion 4526. The medicamentcontainer 4560 is coupled to the carrier 4520 via a “snap-fit”connection (not shown) such that the medicament container 4560 can moverelative to the carrier 4520 between a first configuration and a secondconfiguration during an injection event. In the first configuration, thecarrier 4520 is configured to move within the medicament cavity 4157such that movement of the carrier 4520 within the medicament cavity 4157causes contemporaneous movement of the medicament container 4560 withinthe medicament cavity 4157. The proximal end portion 4516 of the needle4512 is spaced apart from the seal 4523 of the medicament container 4560when the carrier 4520 is in the first configuration. In the secondconfiguration, the medicament container 4560 releases from the“snap-fit” causing the medicament container 4560 to move distally withrespect to the carrier 4520, causing the proximal end portion 4516 ofthe needle 4512 to pierce the seal 4523. In this manner, the needle 4512can be selectively placed in fluid communication with the medicamentcontainer 4560 to define a medicament delivery path (not shown).

FIGS. 13-22 show the electronic circuit system 4900. The electroniccircuit system 4900 of the medical injector 4000 includes an electroniccircuit system housing 4170, a printed circuit board 4922, a batteryassembly 4962, an audio output device 4956, two light emitting diodes(LEDs) 4958A, 4958B and a battery clip 4910. As shown in FIG. 20, theelectronic circuit system 4900 is configured to fit within theelectronic circuit system cavity 4153 of the housing 4110. Accordingly,as described above, the electronic circuit system 4900 is physicallyand/or fluidically isolated from the medicament cavity 4157, the gascavity 4154 and/or the medicament delivery device 4500. As describedherein, the electronic circuit system 4900 is configured to output anelectronic output associated with the use of the medical injector 4000.

The electronic circuit system housing 4170 of the electronic circuitsystem 4900 includes a distal end portion 4180 and a proximal endportion 4190. The proximal end portion 4190 includes connectionprotrusions 4171A and a battery clip protrusion 4173. The connectionprotrusions 4171A extend from the proximal end portion 4190 of theelectronic circuit system housing 4170, and are configured to bedisposed within the connection apertures 4152 of the housing 4110, asdescribed above. In this manner, the electronic circuit system 4900 canbe coupled to the housing 4110 within the electronic circuit systemcavity 4153. In other embodiments, the electronic circuit system 4900can be coupled to the housing 4110 by other suitable means such as anadhesive, a clip and/or the like. As described in more detail herein,the battery clip protrusion 4173 is configured to hold the battery clip4910 in place.

The proximal end portion 4190 of the electronic circuit system housing4170 defines multiple sound apertures 4191. The audible output device4956 is disposed against the proximal end portion 4190 of the electroniccircuit system housing 4170 such that the front face of the audibleoutput device 4956 is disposed adjacent the sound apertures 4191. Inthis manner, the sound apertures 4191 are configured to allow sound froman audio output device 4956 to pass from the audio output device 4956 toa region outside of the housing 4110.

As shown in FIGS. 16 and 17, the distal end portion 4180 of theelectronic circuit system housing 4170 includes a connection protrusion4171B, a stiffening protrusion 4174, and defines an LED aperture 4181,an aperture 4172, a safety lock actuator groove 4182, and a baseactuator groove 4183. The LED aperture 4181 is configured to receive theLEDs 4958A, 4958B such that a user can view the LEDs 4958A, 4958B, whichare described in more detail herein.

The connection protrusion 4171B extends from the distal end portion 4180of the electronic circuit system housing 4170, and is configured toattach the electronic circuit system 4900 to the housing 4110, asdescribed above. The stiffening protrusion 4174 is configured to have atleast a portion received within and/or accessible via the aperture 4145in the housing 4110 (see e.g., FIG. 6). The stiffening protrusion 4174is configured to limit the bending (e.g., buckling) of the electroniccircuit system housing 4170 when the electronic circuit system housing4170 is coupled to the housing 4110. Moreover, a user can access thestiffening protrusion 4174 via the aperture 4172. In this manner, forexample, the user can disengage the stiffening protrusion 4174 from theaperture 4145.

The safety lock actuator groove 4182 of the electronic circuit systemhousing 4170 is configured to be disposed adjacent the safety lockactuator groove 4123 of the distal end portion 4120 of the housing 4110.In this manner, the safety lock actuator groove 4182 of the electroniccircuit system housing 4170 and the safety lock actuator groove 4123 ofthe distal end portion 4120 of the housing 4110 collectively receive theactuator 4744 of the safety lock 4700, which is described in more detailherein. Similarly, the base actuator groove 4183 of the electroniccircuit system housing 4170 is configured to be disposed about the baseactuator groove 4124 of the distal end portion 4120 of the housing 4110.The base actuator groove 4183 of the electronic circuit system housing4170 and the base actuator groove 4124 of the distal end portion 4120 ofthe housing 4110 collectively receive the actuator 4311 of the base4300, which is described in more detail herein.

The printed circuit board 4922 of the electronic circuit system 4900includes a substrate 4924, a first actuation portion 4926 and a secondactuation portion 4946. The substrate 4924 of the printed circuit board4922 includes the electrical components necessary for the electroniccircuit system 4900 to operate as desired. For example, the electricalcomponents can be resistors, capacitors, inductors, switches,microcontrollers, microprocessors and/or the like.

As shown in FIGS. 21-23, the first actuation portion 4926 includes afirst electrical conductor 4934 and defines an opening 4928 having aboundary 4929. The opening 4928 of the first actuation portion 4926 isconfigured to receive a protrusion 4746 of the actuator 4744 of thesafety lock 4700. The boundary 4929 of the first opening 4928 has adiscontinuous shape, such as, for example, a teardrop shape, thatincludes a stress concentration riser 4927. The discontinuity and/or thestress concentration riser 4927 of the boundary 4929 can be of anysuitable shape to cause the substrate 4924 to deform in a predetermineddirection when the protrusion 4746 of the actuator 4744 of the safetylock 4700 is moved relative to the opening 4928, as shown by the arrowCC in FIG. 22.

The opening 4928 is defined adjacent the first electrical conductor 4934that electronically couples the components included in the electroniccircuit system 4900. The first electrical conductor 4934 includes afirst switch 4972, which can be, for example a frangible portion of thefirst electrical conductor 4934. In use, when the safety lock 4700 ismoved from a first position (see e.g., FIG. 21) to a second position(see e.g., FIG. 22), the actuator 4744 moves in a directionsubstantially parallel to a plane defined by a surface of the firstactuation portion 4926 of the substrate 4924. The movement of theactuator 4744 causes the protrusion 4746 to move within the firstopening 4928, as indicated by the arrow CC in FIG. 22. The movement ofthe protrusion 4746 tears the first actuation portion 4926 of thesubstrate 4924, thereby separating the portion of the first electricalconductor 4934 including the first switch 4972. Said another way, whenthe safety lock 4700 is moved from its first position to its secondposition (see e.g., FIG. 33), the actuator 4744 moves irreversibly thefirst switch 4972 from a first state (e.g., a state of electricalcontinuity) to a second state (e.g., a state of electricaldiscontinuity). Said yet another way, when the safety lock 4700 is movedfrom its first position to its second position, the actuator 4744disrupts the first electrical conductor 4934.

The second actuation portion 4946 includes a second electrical conductor4935 and defines an opening 4945, having a boundary 4949 and a tearpropagation limit aperture 4948. As shown in FIGS. 20-23, the opening4945 of the second actuation portion 4946 is configured to receive aportion of an actuator 4311 of the base 4300. The boundary 4949 of theopening 4945 has a discontinuous shape that includes a stressconcentration riser 4947. The discontinuity and/or the stressconcentration riser 4947 of the boundary 4949 can be of any suitableshape to cause the substrate 4924 to deform in a predetermined directionwhen the actuator 4311 of the base 4300 is moved in a proximal directionrelative to the opening 4945, as shown by the arrow DD in FIG. 23.

The second electrical conductor 4935 includes a second switch 4973disposed between the opening 4945 and the tear propagation limitaperture 4948, which can be, for example, a frangible portion of thesecond electrical conductor 4935. In use, when the base 4300 is movedfrom its first position to its second position (see e.g., FIG. 34), theactuator 4311 moves in a proximal direction, substantially parallel to aplane defined by a surface of the second actuation portion 4946 of thesubstrate 4924. The proximal movement of the actuator 4311 tears thesecond actuation portion 4946 of the substrate 4924, thereby separatingthe portion of the second electrical conductor 4935 including the secondswitch 4973. Said another way, when the base 4300 is moved from itsfirst position to its second position, the actuator 4311 movesirreversibly the second switch 4973 from a first state (e.g., a state ofelectrical continuity) to a second state (e.g., a state of electricaldiscontinuity). The tear propagation limit aperture 4948 is configuredto limit the propagation of the tear in the substrate 4924 in theproximal direction. Said another way, the tear propagation limitaperture 4948 is configured to ensure that the tear in the substrate4924 does not extend beyond the tear propagation limit aperture 4948.The tear propagation limit aperture 4948 can be any shape configured tostop the propagation of a tear and/or disruption of the substrate 4924.For example, the tear propagation limit aperture 4948 can be ovalshaped. In other embodiments, the proximal boundary of the tearpropagation limit aperture 4948 can be reinforced to ensure that thetear in the substrate 4924 does not extend beyond the tear propagationlimit aperture 4948.

The battery assembly 4962 of the electronic circuit system 4900comprises two batteries stacked on top of one another. The batteryassembly 4962 has a first surface 4964 and a second surface 4966. Thefirst surface 4964 of the battery assembly 4962 can contact anelectrical contact (not shown) disposed on the substrate 4924. Thesecond surface 4966 of the battery assembly 4962 is configured tocontact a contact portion 4918 of a distal end portion 4916 of a batteryclip 4910. When both the electrical contact of the substrate 4924 andthe contact portion 4918 of the distal end portion 4916 of the batteryclip 4910 contact the battery assembly 4962, the batteries of thebattery assembly 4962 are placed in electrical communication with theelectronic circuit system 4900. Said another way, when the electricalcontact of the substrate 4924 and the contact portion 4918 of the distalend portion 4916 of the battery clip 4910 contact the battery assembly4962, the battery assembly 4962 is configured to supply power to theelectronic circuit system 4900.

The battery clip 4910 (shown in FIG. 18) includes a proximal end portion4912 and a distal end portion 4916. The proximal end portion 4912defines a retention aperture 4913. The retention aperture 4913 isconfigured to receive the battery clip protrusion 4173 of the electroniccircuit system housing 4170. In this manner, the battery clip protrusion4173 maintains the position of the battery clip 4910 with respect to theelectronic circuit system housing 4170 and/or the battery assembly 4962.

The distal end portion 4916 of the battery clip 4910 includes a contactportion 4918 and an angled portion 4917. As described above, the contactportion 4918 is configured to contact the second surface 4916 of thebattery assembly 4962 to place the battery assembly 4962 in electricalcommunication with the electronic circuit system 4900. The angledportion 4917 of the distal end portion 4916 of the battery clip 4910 isconfigured to allow a proximal end portion 4236 of a battery isolationprotrusion 4235 (see e.g., FIG. 25) to be disposed between the secondsurface 4966 of the battery assembly 4962 and the contact portion 4918of the distal end portion 4916 of the battery clip 4910. When thebattery isolation protrusion 4235 is disposed between the second surface4966 of the battery assembly 4962 and the contact portion 4918 of thedistal end portion 4916 of the battery clip 4910, the electrical pathbetween the battery assembly 4962 and the remainder of the electricalcircuit system 4900 is severed, thereby removing power from theelectronic circuit system 4900. The contact portion 4918 of the distalend portion 4916 of the battery clip 4910 is biased such that when thebattery isolation protrusion 4235 is removed, the contact portion 4918will move into contact the second surface 4916 of the battery assembly4962, thereby restoring electrical communication between the batteryassembly 4962 and the electronic circuit system 4900. In someembodiments, the battery isolation protrusion 4235 can be repeatedlyremoved from between the second surface 4966 of the battery assembly4962 and the contact portion 4918 of the distal end portion 4916 of thebattery clip 4910 and reinserted. Said another way, the batteryisolation protrusion 4235 and the battery clip 4910 collectively form areversible on/off switch.

The audio output device 4956 of the electronic circuit system 4900 isconfigured to output audible sound to a user in response to a use of themedical injector 4000. In some embodiments, the audible output device4956 can be a speaker. In some embodiments, the audible sound can be,for example, associated with a recorded message and/or a recordedspeech. In other embodiments, the audible instructions can be an audiblebeep, a series of tones and/or or the like.

In other embodiments, the medical injector 4000 can have a networkinterface device (not shown) configured to operatively connect theelectronic circuit system 4900 to a remote device (not shown) and/or acommunications network (not shown). In this manner, the electroniccircuit system 4900 can send information to and/or receive informationfrom the remote device. The remote device can be, for example, a remotecommunications network, a computer, a compliance monitoring device, acell phone, a personal digital assistant (PDA) or the like. Such anarrangement can be used, for example, to download replacementprocessor-readable code from a central network to the electronic circuitsystem 4900. In some embodiments, for example, the electronic circuitsystem 4900 can download information associated with a medical injector4000, such as an expiration date, a recall notice, updated useinstructions or the like. Similarly, in some embodiments, the electroniccircuit system 4900 can upload compliance information associated withthe use of the medical injector 4000 via the network interface device.

FIGS. 24 and 25 show the cover 4200 of the medical injector 4000. Thecover 4200 includes a proximal end portion 4210 and a distal end portion4230, and defines a cavity 4242. The cavity 4242 of the cover 4200 isconfigured to receive at least a portion of the housing 4110. Theproximal end portion 4210 defines apertures 4215 configured to receivethe cover retention protrusions 4142 of the housing 4110 (shown in FIGS.4 and 6). In this manner, the apertures 4215 and the cover retentionprotrusions 4142 of the housing 4110 removably retain the cover 4200about at least a portion of the housing 4110. Said another way, theapertures 4215 and the cover retention protrusions 4142 of the housing4110 are configured such that the cover 4200 can be removed from aportion of the housing 4110 and then replaced about the portion of thehousing 4110.

The distal end portion 4230 of the cover 4200 includes a batteryisolation protrusion 4235. The battery isolation protrusion 4235includes a proximal end portion 4236 and a tapered portion 4237. Theproximal end portion 4236 of the battery isolation protrusion 4235 isconfigured to be removably disposed between the second surface 4966 ofthe battery assembly 4962 and the contact portion 4918 of the distal endportion 4916 of the battery clip 4910, as described above.

FIGS. 26-29 show the safety lock 4700 of the medical injector 4000. Thesafety lock 4700 of the medical injector 4000 includes a proximalsurface 4740, a distal surface 4760 opposite the proximal surface 4740and a needle sheath 4720. The safety lock 4700 defines a needle sheathaperture 4770 and a battery isolation protrusion aperture 4775. Thebattery isolation protrusion aperture 4775 is configured to receive thebattery isolation protrusion 4235 of the cover 4200 such that thebattery isolation protrusion 4235 can be disposed within the electroniccircuit system cavity 4153 or the electronic circuit system 4900, asdescribed above. Similarly stated, the battery isolation protrusionaperture 4775 of the safety lock 4700 is aligned with the batteryisolation protrusion aperture 4121 of the housing 4110, such that thebattery isolation protrusion 4235 can be disposed within the electroniccircuit system cavity 4153 when the cover 4200 is disposed about aportion of the housing 4110.

The proximal surface 4740 of the safety lock 4700 includes a safety lockprotrusion 4742, a stopper 4743, an actuator 4744 and two opposing pulltabs 4741. As described above, when the safety lock 4700 is in a first(locked) position, the safety lock protrusion 4742 is configured to bedisposed in the opening 4554 defined by the extensions 4552 of thedistal end portion 4544 of the release member 4540. Accordingly, thesafety lock protrusion 4742 is configured to prevent the extensions 4552from moving closer to each other, thereby preventing proximal movementof the release member 4540 of the medicament delivery mechanism 4500and/or delivery of a medicament. The stopper 4743 of the safety lock4700 is a protrusion extending from the proximal surface 4740 of thesafety lock 4700. The stopper 4743 is configured to contact a portion ofthe housing 4110 to limit the proximal movement of the safety lock 4700relative to the housing 4110. In other embodiments, the stopper 4743 canbe any structure configured to limit the proximal movement of the safetylock 4700.

The actuator 4744 of the safety lock 4700 has an elongated portion 4745and a protrusion 4746. The elongated portion 4745 extends in a proximaldirection from the proximal surface 4740. In this manner, the elongatedportion 4745 can extend through a safety lock actuator opening 4356 ofthe base 4300 (see e.g., FIG. 30) and within the safety lock actuatorgroove 4123 of the housing 4110 and the safety lock actuator groove 4182of the electronic circuit system housing 4170. The protrusion 4746extends in a direction substantially transverse to the elongated portion4745 and/or substantially parallel to the proximal surface 4740 of thesafety lock 4700. As described above, the opening 4928 of the firstactuation portion 4926 is configured to receive the protrusion 4746 ofthe actuator 4744 of the safety lock 4700.

The pull tabs 4741 of the safety lock 4700 include a grip portion 4747and indicia 4748. The grip portion 4747 of the pull tabs 4741 providesan area for the user to grip and/or remove the safety lock 4700 from therest of the medicament delivery system 4700. The indicia 4748 providesinstruction on how to remove the safety lock 4700. In some embodiments,for example, the indicia 4748 can indicate the direction the user shouldpull the safety lock 4700 to remove the safety lock 4700.

As shown in FIG. 28, the needle sheath 4720 of the safety lock 4700includes a distal end portion 4724, a proximal end portion 4722 and aplurality of ribs 4728. The needle sheath 4720 can also define a lumen4729. The lumen 4729 of the safety lock 4700 is configured to receivethe needle 4512. In this manner, the needle sheath 4720 can protect theuser from the needle 4512 and/or can keep the needle 4512 sterile beforethe user uses the medical injector 4000. The proximal end portion 4722of the needle sheath is configured to contact the distal end portion4522 of the carrier 4520 of the medicament delivery mechanism 4500.

The distal end portion 4724 of the needle sheath 4720 has an angledridge 4725. The angled ridge 4725 is configured to allow the proximalend portion 4722 of the needle sheath 4720 to irreversibly move throughthe needle sheath aperture 4770 of the safety lock 4700 in a distaldirection. Said another way, the angled ridge 4725 can be configured insuch a way as to allow the proximal end portion 4722 of the needlesheath 4720 to move through the needle sheath aperture 4770 in a distaldirection, but not in a proximal direction. The needle sheath aperture4770 has retaining tabs 4771 configured to engage the proximal end ofthe angled ridge 4725 when the needle sheath 4720 is moved in a proximaldirection. In this manner, the retaining tabs 4771 prevent the proximalmovement of the needle sheath with respect to the safety lock 4700.Further, the retaining tabs 4771 are configured to engage the proximalend of the angled ridge 4725 when the safety lock 4700 is moved in adistal direction. Said another way, as shown in FIG. 33, the needlesheath 4720 is removed from the needle 4512 when the safety lock 4700 ismoved in a distal direction with respect to the housing 4110.

FIGS. 30-31 show the base 4300 of the medical injector 4000. The base4300 includes a proximal surface 4310, a distal surface 4330 and baseconnection knobs 4358. The base 4300 defines a needle aperture 4350, asafety lock protrusion aperture 4352, a battery isolation protrusionaperture 4354, a safety lock actuator opening 4356, and pull tabopenings 4360. The needle aperture 4350 is configured to receive theneedle 4512 when the medical injector 4000 is actuated. The safety lockprotrusion aperture 4352 of the base 4300 receives the safety lockprotrusion 4742 of the safety lock 4700. The battery isolationprotrusion aperture 4354 of the base 4300 receives the battery isolationprotrusion 4235 of the cover 4200 and the stopper 4743 of the safetylock 4700. The safety lock actuator opening 4356 receives the safetylock actuator 4744 of the safety lock 4700. The pull tab openings 4360are configured to receive the pull tabs 4741 of the safety lock 4700.

The proximal surface 4310 of the base 4300 includes an actuator 4311,guide members 4312, and protrusions 4313. The actuator 4311 is anelongate member configured to engage the substrate 4924 of theelectronic circuit system 4900. As described above, the opening 4945 ofthe second actuation portion 4946 is configured to receive the actuator4311 of the base 4300. The guide members 4312 of the base 4300 areconfigured to engage and/or slide within the base rail grooves 4127 ofthe housing 4110, as described above. The protrusions 4313 of the base4300 are configured to engage the tapered surfaces 4549 of theextensions 4552 of the release member 4540. As described in furtherdetail herein, when the safety lock 4700 is removed and the base 4300 ismoved in a proximal direction with respect to the housing 4110, theprotrusion 4313 of the base 4300 are configured to move the extensions4552 of the release member 4540 closer to each other, actuating themedicament delivery mechanism 4500. As described above, the baseconnection knobs 4358 are configured to engage the base retentionrecesses 4125A, 4125B in a way that allows proximal movement of the base4300 but limits distal movement of the base 4300.

As shown in FIG. 32, the medical injector 4000 is first enabled bymoving the medicament delivery device from a first configuration to asecond configuration by moving the cover 4200 from a first position to asecond position. The cover 4200 is moved from the first position to thesecond position by moving it with respect to the housing 4110 in thedirection shown by the arrow EE in FIG. 32. When the cover 4200 is movedwith respect to the housing 4110 in the direction EE, the batteryisolation protrusion 4235 is removed from the area between the batteryclip 4910 and the second surface 4966 of the battery assembly 4962. Inthis manner, the battery assembly 4962 can be operatively coupled to theelectronic circuit system 4900 when the cover 4200 is removed, therebyproviding power to the electronic circuit system 4900.

When power is provided, as described above, the electronic circuitsystem 4900 can output one or more predetermined electronic outputs. Forexample, in some embodiments, the electronic circuit system 4900 canoutput an electronic signal associated with recorded speech to theaudible output device 4956. Such an electronic signal can be, forexample, associated with a .WAV file that contains a recordedinstruction instructing the user in the operation of the medicalinjector 4000. Such an instruction can state, for example, “remove thesafety tab near the base of the auto-injector.” The electronic circuitsystem 4900 can simultaneously output an electronic signal to one and/orboth of the LEDs 4958A, 4958B thereby causing one and/or both of theLEDs 4958A, 4958B to flash a particular color. In this manner, theelectronic circuit system 4900 can provide both audible and visualinstructions to assist the user in the initial operation of the medicalinjector 4000.

In other embodiments, the electronic circuit system 4900 can output anelectronic output associated with a description and/or status of themedical injector 4000 and/or the medicament contained therein. Forexample, in some embodiments, the electronic circuit system 4900 canoutput an audible message indicating the type of medicament contained inthe medical injector 4000, the expiration date of the medicament, thedosage of the medicament or the like.

As described above, the medical injector 4000 can be can be repeatedlymoved between the first configuration and the second configuration whenthe cover 4200 is moved repeatedly between the first position and thesecond position respectively. Said another way, the cover 4200 can beremoved and replaced about the housing 4110 any number of times. Whenthe cover 4200 is moved from the second position to the first position,the battery isolation protrusion 4235 is inserted between the batteryclip 4910 and the second surface 4966 of the battery assembly 4962,deactivating the electronic circuit system 4900. When the cover is movedfrom the first position to the second position a second time, theelectronic circuit system 4900 is once again activated. In this manner,the cover 4200 can be removed and the electronic circuit system 4900 canoutput an electronic output without compromising the sterility of theneedle 4512.

After the cover 4200 is removed from the housing 4110, the medicalinjector 4000 can be moved from the second configuration to a thirdconfiguration by moving the safety lock 4700 from a first position to asecond position. The safety lock 4700 is moved from a first position toa second position by moving the safety lock 4700 with respect to thehousing 4110 in the direction shown by the arrow FF in FIG. 33. When thesafety lock 4700 is moved from the first position to the secondposition, the safety lock protrusion 4742 is removed from between theextensions 4552 of the release member 4540, thereby enabling themedicament delivery member 4500. Moreover, as shown in FIGS. 21 and 22,when the safety lock 4700 is moved from the housing 4110, the actuator4744 of the safety lock 4700 moves in the direction CC as shown in FIG.22, irreversibly moving the first switch 4972 from a first state (e.g.,a state of electrical continuity) to a second state (e.g., a state ofelectrical discontinuity). When the actuator 4744 of the safety lock4700 moves irreversibly the first switch 4972 of the electronic circuitsystem 4900 to the second state, the electronic circuit system 4900 canoutput one or more predetermined electronic outputs. For example, insome embodiments, a processor (not shown) can output an electronicsignal associated with recorded speech to the audible output device4956. Such an electronic signal can be, for example, associated with arecorded message notifying the user of the status of the medicalinjector 4000. Such a status message can state, for example, “Themedical injector is now enabled.” The electronic circuit system 4900 canalso simultaneously output an electronic signal to one and/or both ofthe LEDs 4958A, 4958B, thereby causing one and/or both of the LEDs4958A, 4958B to stop flashing, change color or the like.

In some embodiments, the first actuation portion 4926 and the actuator4744 can be configured such that the actuator 4744 must move apredetermined distance before the actuator 4744 engages the boundary4929 of the opening 4928. For example, in some embodiments, the actuator4744 must move approximately 0.200 inches before the actuator 4744engages the boundary 4929 of the opening 4928. In this manner, thesafety lock 4700 can be moved slightly without irreversibly moving thefirst switch 4972 of the electronic circuit system 4900 to the secondstate. Accordingly, this arrangement will permit the user toinadvertently and/or accidentally move the safety lock 4700 withoutactuating the electronic circuit system 4900.

In some embodiments, the electronic circuit system 4900 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4900 can output an audiblemessage further instructing the user in the operation of the medicalinjector 4000. Such an instruction can state, for example, “Place thebase of the auto-injector against the patient's thigh. To complete theinjection, press the base firmly against the patient's thigh.” In someembodiments, the electronic circuit system 4900 can simultaneouslyoutput an electronic signal to one and/or both of the LEDs 4958A, 4958B,thereby causing one and/or both of the LEDs 4958A, 4958B to flash aparticular color. In this manner, the electronic circuit system 4900 canprovide both audible and/or visual instructions to assist the user inthe placement and actuation of the medical injector 4000. In someembodiments, the electronic circuit system 4900 can be configured torepeat the instructions after a predetermined time period has elapsed.

As described above, in other embodiments, the medical injector 4000 canhave a network interface device (not shown) configured to operativelyconnect the electronic circuit system 4900 to a remote device (notshown) and/or a communications network (not shown). In this manner, theelectronic circuit system 4900 can send a wireless signal notifying aremote device that the safety lock 4700 of the medical injector 4000 hasbeen removed and that the medical injector 4000 has been armed.

After the safety lock 4700 is moved from the first position to thesecond position, the medical injector 4000 can be moved from the thirdconfiguration to a fourth configuration by moving the base 4300 from afirst position to a second position. The base 4300 is moved from itsfirst position to its second position by placing the medical injector4000 against the body of the patient and moving the base 4300 withrespect to the housing 4110 in the direction shown by the arrow GG inFIG. 34. Moving the base 4300 from the first position to the secondposition causes the protrusions 4313 on the proximal surface 4310 of thebase 4300 to engage the tapered surfaces 4549 of the extensions 4552 ofthe release member 4540, causing the release member 4540 to actuate themedicament delivery mechanism 4500 and deliver a medicament to a body ofa patient.

When the base 4300 is moved from the first position to the secondposition, the medicament delivery mechanism 4500 is actuated such thatthe puncturer 4541 of the release member 4540 is brought in contact withand/or punctures the frangible seal 4573 of the gas container 4570. Insome embodiments, the movement of the release member 4540 can be causedby a spring (not shown in FIG. 12). After the frangible seal 4573 hasbeen punctured, an actuating portion of a compressed gas can escape fromthe gas container 4570 and flow via the gas passageway 4144 into themedicament cavity 4157. The gas applies gas pressure to the movablemember 4530 causing the movable member 4530 and the carrier 4520 to movein a distal direction within the medicament cavity 4157. When thecarrier 4520 moves distally within the medicament cavity 4157, thecarrier 4520 and the medicament container 4560 are in a firstconfiguration. Accordingly, as described above, the medicament container4560 is connected to the carrier 4520 by a “snap fit” connection. Inthis manner, the medicament container 4560 and the needle 4512contemporaneously move with movable member 4530 and/or the carrier 4520in a distal direction. As described above, the proximal end portion 4516of the needle 4512 is connected to the distal end portion 4522 of thecarrier 4520 and is spaced from the seal 4523 of the medicamentcontainer 4560 when the carrier 4520 is in its first configuration. Saidanother way, the medicament container 4560 and the needle 4512 do notdefine a medicament delivery path when the carrier 4520 is in the firstconfiguration. The movement of the needle 4512 in a distal directioncauses the proximal end portion 4516 of the needle 4512 to exit thehousing 4110 and enter the body of a patient prior to administering amedicament.

After the carrier 4520 and/or the needle 4512 have moved within themedicament cavity 4157 a predetermined distance, the carrier 4520 andthe medicament container 4560 are moved from the first configuration toa second configuration. In the second configuration of the carrier 4520,the medicament container 4560 is released from the “snap-fit” allowingthe medicament container 4560 and the movable member 4530 to continue tomove in a distal direction relative to the carrier 4520. Said anotherway, the medicament container 4560 is configured to slidably move withinthe carrier 4520 when the carrier is moved from the first configurationto the second configuration. As the medicament container 4560 continuesto move within the carrier 4520, the proximal end portion 4516 of theneedle 4512 contacts and punctures the seal 4523 of the medicamentcontainer 4560. This allows the medicament contained in the medicamentcontainer 4560 to flow into the lumen (not shown) defined by the needle4512, thereby defining a medicament delivery path.

As the medicament container 4560 contacts the distal end of the carrier4520, the medicament container 4560 stops moving within the carrier 4520while the movable member 4530 continues to move in a distal direction.This causes the piston portion 4534 of the movable member 4530 tosealingly slide and/or move within the medicament container 4560containing a liquid medicament. As the piston portion 4534 of themovable member 4530 sealingly slides and/or moves within the medicamentcontainer 4560, the piston portion 4534 generates a pressure upon themedicament contained within the medicament container 4560, therebyallowing at least a portion of the medicament to flow out of themedicament container 4560 and into the lumen defined by the needle 4512.The medicament is delivered to a body of a user via the medicamentdelivery path defined by the medicament container 4560 and the needle4512.

As described above, the actuator 4538 of the base 4300 actuates theelectronic circuit 4900 to trigger a predetermined output or sequence ofoutputs when the base 4520 is moved from its first position to itssecond position (see, e.g., FIGS. 19-23). When the actuator 4538 ismoved in a proximal direction relative to the opening 4945, as shown bythe arrow DD in FIG. 23, the electronic circuit system 4900 is actuatedto output one or more predetermined electronic outputs. For example, insome embodiments, the electronic circuit system 4900 can output anelectronic signal associated with recorded speech to the audible outputdevice 4956. Such an electronic signal can be, for example, associatedwith an audible countdown timer, instructing the user on the duration ofthe injection procedure. Said another way, if it takes, for example, tenseconds to complete an injection, an audible countdown timer can countfrom ten to zero ensuring that the user maintains the medical injector4000 in place for the full ten seconds. In other embodiments, theelectronic signal can be, for example, associated with a recordedmessage notifying the user that the injection is complete, instructingthe user on post-injection disposal and safety procedures, instructingthe user on post-injection medical treatment or the like. Such a statusmessage can state, for example, “The injection is now complete. Pleaseseek further medical attention from a doctor.” The electronic circuitsystem 4900 can also simultaneously output an electronic signal to oneand/or both LEDs 4958A, 4958B, thereby causing one and/or both LEDs4958A, 4958B to stop flashing, change color or the like, to provide avisual indication that the injection is complete. In other embodiments,the electronic circuit system 4900 can send a wireless signal notifyinga remote device that the injection is complete. In this manner, apatient's compliance can be monitored.

In some embodiments, the second actuation portion 4946 and the actuator4538 can be configured such that the base 4500 and/or the actuator 4538must move a predetermined distance before the actuator 4538 engages theboundary 4949 of the opening 4945. For example, in some embodiments, theactuator 4538 must move approximately 0.200 inches before the actuator4538 engages the boundary 4949 of the opening 4945. In this manner, thebase 4700 can be moved slightly without irreversibly moving the secondswitch 4973 of the electronic circuit system 4900 to the second state.Accordingly, this arrangement will permit the user to inadvertentlyand/or accidentally move the base 4500 without actuating the electroniccircuit system 4900.

Although the electronic circuit system 4900 is shown and described aboveas having two irreversible switches (e.g., switch 4972 and switch 4973),in other embodiments, an electronic circuit system can have any numberof switches. Moreover, such switches can be either reversible orirreversible. For example, FIGS. 35-40 show portions of a medicamentdelivery device 5000 having an electronic circuit system 5900 havingthree irreversible switches.

The medicament delivery device 5000 is similar to the medical injector4000 described above. As shown in FIG. 39, the medicament deliverydevice 5000 includes a housing 5110, a delivery mechanism (not shown),an electronic circuit system 5900, a cover (not shown), a safety lock5700 and a base 5300. The structure and operation of the deliverymechanism, the cover, the safety lock 5700 and the base 5300 are similarto the structure and operation of the delivery mechanism 4500, the cover4200, the safety lock 4700 and the base 4300, respectively. Accordingly,only the electronic circuit system 5900 and the housing 5110 aredescribed in detail below.

As shown in FIG. 35, the housing 5110 has a proximal end portion 5140and a distal end portion 5120. The housing 5110 defines a gas cavity(not shown), a medicament cavity (not shown) and an electronic circuitsystem cavity 5153. The gas cavity and medicament cavity of the housing5110 of the medicament delivery device 5000 are similar to the gascavity 4154 and the medicament cavity 4157, shown and described abovewith reference to FIGS. 9 and 10.

The electronic circuit system cavity 5153 is configured to receive theelectronic circuit system 5900. As described above, the electroniccircuit system cavity 5153 is fluidically and/or physically isolatedfrom the gas cavity and/or the medicament cavity by a sidewall 5148. Thehousing 5110 has protrusions 5149 configured to stabilize the electroniccircuit system 5900 when the electronic circuit system 5900 is disposedwithin the electronic circuit system cavity 5153. The housing 5110 alsodefines connection apertures (not shown) configured to receiveconnection protrusions 5171 of the electronic circuit system 5900 (seee.g., FIG. 36). In this manner, the electronic circuit system 5900 canbe coupled to the housing 5110 within the electronic circuit systemcavity 5153 (see e.g., FIG. 39). In other embodiments, the electroniccircuit system 5900 can be coupled within the electronic circuit systemcavity 5153 by any other suitable means, such as an adhesive, a clipand/or the like.

The housing 5110 includes an actuation protrusion 5114 disposed withinthe electronic circuit system cavity 5153. As described in more detailherein, an angled end portion 5115 of the actuation protrusion 5114 ofthe housing 5110 is configured to engage a third actuation portion 5976of a substrate 5924 of the electronic circuit system 5900 when theelectronic circuit system 5900 is coupled to the housing 5110.

As shown in FIGS. 39, the electronic circuit system 5900 is configuredto fit within the electronic circuit system cavity 5153 of the housing5110. Accordingly, as described above, the electronic circuit system5900 is physically and/or fluidically isolated from the medicamentcavity, the gas cavity and/or the medicament delivery path within themedicament delivery device 5000 (not shown). As described herein, theelectronic circuit system 5900 is configured to output an electronicoutput associated with a use of the medicament delivery device 5000.

As shown in FIG. 36, the electronic circuit system 5900 is similar tothe electronic circuit system 4900 described above. The electroniccircuit system 5900 of the medicament delivery device 5000 includes anelectronic circuit system housing 5170, a printed circuit board 5922, abattery assembly 5962, an audio output device 5956, two light emittingdiodes (LEDs) 5958A, 5958B and a battery clip 5910. The electroniccircuit system housing 5170, the battery assembly 5962, the audio outputdevice 5956 electrically coupled to the printed circuit board 5922 viawires 5955, the two light emitting diodes (LEDs) 5958A, 5958B and thebattery clip 5910 are similar to the battery assembly 4962, the audiooutput device 4956, the two light emitting diodes (LEDs) 4958A, 4958Band the battery clip 4910 of the electronic circuit system 4900described above. Thus, a detailed discussion of these components isomitted.

The electronic circuit system 5900 also includes a processor 5950configured to process electronic inputs (e.g., from input switches) andproduce electronic outputs. As described herein, such electronic outputscan include audio or visual outputs associated with a use of themedicament delivery device 5000. The processor 5950 can be acommercially-available processing device dedicated to performing one ormore specific tasks. For example, in some embodiments, the processor5950 can be a commercially-available microprocessor, such as the SonixSNC 12060 voice synthesizer. Alternatively, the processor 5950 can be anapplication-specific integrated circuit (ASIC) or a combination ofASICs, which are designed to perform one or more specific functions. Inyet other embodiments, the processor 5950 can be an analog or digitalcircuit, or a combination of multiple circuits.

The processor 5950 can include a memory device (not shown) configured toreceive and store information, such as a series of instructions,processor-readable code, a digitized signal, or the like. The memorydevice can include one or more types of memory. For example, the memorydevice can include a read only memory (ROM) component and a randomaccess memory (RAM) component. The memory device can also include othertypes of memory suitable for storing data in a form retrievable by theprocessor 5950, for example, electronically-programmable read onlymemory (EPROM), erasable electronically-programmable read only memory(EEPROM), or flash memory.

FIG. 37 shows the printed circuit board 5922 of the electronic circuitsystem 5900. FIG. 38 is a schematic illustration of the electroniccircuit system 5900. The printed circuit board 5922 of the electroniccircuit system 5900 includes a substrate 5924, a first actuation portion5926 (including a first switch 5972), a second actuation portion 5946(including a second switch 5973), and a third actuation portion 5976(including an electronic circuit system configuration switch 5974). Thesubstrate 5924 of the printed circuit board 5922 includes the electricalcomponents necessary for the electronic circuit system 5900 to operateas desired. For example, the electrical components can includeresistors, capacitors, inductors, switches, microcontrollers,microprocessors and/or the like.

The first actuation portion 5926 and the second actuation portion 5946are similar to the first actuation portion 4926 and the second actuationportion 4946 of the electronic circuit system 4900, described above (seee.g., FIG. 36), and are therefore not described or labeled in detail.The third actuation portion 5976 includes a third electrical conductor5936 (see e.g., FIG. 37) and defines an actuation aperture 5975 having aboundary 5979, and a tear propagation limit aperture 5978. As shown inFIGS. 36 and 40, the actuation aperture 5975 of the third actuationportion 5976 is configured to receive the angled end portion 5115 of theactuation protrusion 5114 of the housing 5110 when the electroniccircuit system 5900 is disposed within the electronic circuit systemcavity 5153. The boundary 5979 of the actuation aperture 5975 has adiscontinuous shape, such as, for example, a teardrop shape, thatincludes a stress concentration riser 5977. The discontinuity and/or thestress concentration riser 5977 of the boundary 5979 can be of anysuitable shape to cause the substrate 5924 to deform in a predetermineddirection when the angled end portion 5115 of the actuation protrusion5114 of the housing 5110 is inserted into the actuation aperture 5975(see e.g., FIG. 40), as described below.

The third electrical conductor 5936 includes the electronic circuitsystem configuration switch 5974 (see e.g., FIG. 37) disposed betweenthe actuation aperture 5975 and the tear propagation limit aperture5978, which can be, for example, a frangible portion of the thirdelectrical conductor 5436. As shown in FIGS. 39 and 40, when theelectronic circuit system 5900 is attached to the housing 5110, aportion of the angled portion 5115 of the actuation protrusion 5114 isdisposed within the actuation aperture 5975 of the third actuationportion 5976, as shown by the arrow HH in FIG, 40. Continued movement ofthe angled portion 5115 of the actuation protrusion 5114 within thethird actuation portion 5976 of the substrate 5924 causes the thirdactuation portion 5976 of the substrate 5924 to tear, thereby separatingthe portion of the third electrical conductor 5936 including theelectronic circuit system configuration switch 5974. Said another way,when the electronic circuit system 5900 is attached to the housing 5110,the actuation protrusion 5114 moves irreversibly the electronic circuitsystem configuration switch 5974 from a first state (e.g., a state ofelectrical continuity) to a second state (e.g., a state of electricaldiscontinuity).

The tear propagation limit aperture 5978 is configured to limit thepropagation of the tear in the substrate 5924. Said another way, thetear propagation limit aperture 5978 is configured to ensure that thetear in the substrate 5924 does not extend beyond the tear propagationlimit aperture 5978. The tear propagation limit aperture 5978 can be anyshape configured to limit the propagation of a tear and/or disruption ofthe substrate 5924. For example, the tear propagation limit aperture5978 can be oval shaped. In other embodiments, the boundary of the tearpropagation limit aperture 5978 can be reinforced to ensure that thetear in the substrate 5924 does not extend beyond the tear propagationlimit aperture 5978. The angled end portion 5115 of the actuationprotrusion 5114 ensures that the tear in the substrate 5924 propagatesin the desired direction. Said another way, the angled end portion 5115of the actuation protrusion 5114 ensures that the tear in the substrate5924 occurs between the actuation aperture 5975 and the tear propagationlimit aperture 5978.

When the actuation protrusion 5114 of the housing 5110 movesirreversibly the electronic circuit system configuration switch 5974 ofthe electronic circuit system 5900 from the first state to the secondstate, the electronic circuit system 5900 can be moved between a firstconfiguration and a second configuration. For example, in someembodiments, irreversibly moving the electronic circuit systemconfiguration switch 5974 of the electronic circuit system 5900 to thesecond state places the electronic circuit system 5900 in the secondconfiguration such that when power is applied to the electronic circuitsystem 5900, the electronic circuit system 5900 recognizes that themedicament delivery device 5000 is a certain type of medicament deliverydevice and/or is in a certain configuration. In some embodiments, thehousing can be devoid of the actuation protrusion 5114, thus theelectronic circuit system configuration switch 5974 is maintained in itsfirst state when the electronic circuit system 5900 is attached to thehousing 5110. In this manner, the electronic circuit systemconfiguration switch 5974 can enable the electronic circuit system 5900to be used in different types and/or configurations of medicamentdelivery devices. The dual functionality of the electronic circuitsystem 5900 enables production of the same electronic circuit system5900 for multiple devices, thereby permitting mass production anddecreasing the cost of production of the electronic circuit system 5900.

For example, in some embodiments the electronic circuit system 5900 canbe used in either an actual medicament delivery device or a simulatedmedicament delivery device. A simulated medicament delivery device can,for example, correspond to an actual medicament delivery device and canbe used, for example, to train a user in the operation of thecorresponding actual medicament delivery device.

The simulated medicament delivery device can simulate the actualmedicament delivery device in any number of ways. For example, in someembodiments, the simulated medicament delivery device can have a shapecorresponding to a shape of the actual medicament delivery device, asize corresponding to a size of the actual medicament delivery deviceand/or a weight corresponding to a weight of the actual medicamentdelivery device. Moreover, in some embodiments, the simulated medicamentdelivery device can include components that correspond to the componentsof the actual medicament delivery device. In this manner, the simulatedmedicament delivery device can simulate the look, feel and sounds of theactual medicament delivery device. For example, in some embodiments, thesimulated medicament delivery device can include external components(e.g., a housing, a needle guard, a sterile cover, a safety lock or thelike) that correspond to external components of the actual medicamentdelivery device. In some embodiments, the simulated medicament deliverydevice can include internal components (e.g., an actuation mechanism, acompressed gas source, a medicament container or the like) thatcorrespond to internal components of the actual medicament deliverydevice.

In some embodiments, however, the simulated medicament delivery devicecan be devoid of a medicament and/or those components that cause themedicament to be delivered (e.g., a needle, a nozzle or the like). Inthis manner, the simulated medicament delivery device can be used totrain a user in the use of the actual medicament delivery device withoutexposing the user to a needle and/or a medicament. Moreover, thesimulated medicament delivery device can have features to identify it asa training device to prevent a user from mistakenly believing that thesimulated medicament delivery device can be used to deliver amedicament. For example, in some embodiments, the simulated medicamentdelivery device can be of a different color than a corresponding actualmedicament delivery device. Similarly, in some embodiments, thesimulated medicament delivery device can include a label clearlyidentifying it as a training device.

The actuation of the medicament delivery device configuration switch5974 can configure the electronic circuit system 5900 to output adifferent electronic output when the medicament delivery device 5000 isa simulated medical injector than when the medicament delivery device5000 is an actual medical injector. Said yet another way, the electroniccircuit system 5900 can be configured to output a first series ofelectronic outputs when the electronic circuit system configurationswitch 5974 is in the first state and a second series of electronicoutputs when the electronic circuit system configuration switch 5974 isin the second state. In this manner, the electronic circuit systemconfiguration switch 5974 can enable the same electronic circuit system5900 to be used in both simulated medicament delivery devices and actualmedicament delivery devices. When used on an actual medicament deliverydevice, for example, the housing can be devoid of the actuationprotrusion 5114. The dual functionality of the electronic circuit system5900 can decrease the cost of production of the electronic circuitsystem 5900 of the medicament delivery device 5000.

In other embodiments, moving the electronic circuit system configurationswitch 5974 to the second state can place the electronic circuit system5900 in any number of different functional configurations. For example,moving the electronic circuit system configuration switch 5974 from thefirst state to the second state can indicate the type of medicament inthe medicament container, the dosage of the medicament and/or thelanguage of the audible electronic outputs output by the electroniccircuit system 5900.

In still other embodiments, any number of electronic circuit systemconfiguration switches can be used. For example, multiple switches canbe used to configure the electronic circuit system 5900 to output usageinstructions in any number of languages. For example, if an electroniccircuit system contained three configuration switches (e.g., switches A,B and C), switch A can correspond to English instructions, switch B toSpanish instructions and switch C to German instructions. Further,moving both switch A and B to the second state might correspond toFrench instructions. In this manner, a single electronic circuit system5900 can be configured to output instructions in multiple languages.

FIG. 41 is a flow chart of a method 100 according to an embodiment ofthe invention. The method includes assembling a medical deviceconfigured to deliver a medicament into a body of a patient, 102. Themedical device includes a housing, a medicament container disposedwithin the housing, an actuator, and a safety lock. In some embodiments,the housing, medical container, the actuator, and the safety lock can besimilar to the corresponding components in the medical injector 4000and/or the medicament delivery device 5000, described above. Theactuator of the medical device is configured to initiate delivery of themedicament from the medicament container when the actuator is actuated.The safety lock of the medical device is configured to prevent actuationof the actuator.

After the medical device is assembled, at least a portion of the medicaldevice can optionally be sterilized, 104. Various sterilizationtechniques may be utilized. In some embodiments, a suitablesterilization technique includes the use of one or more of ethyleneoxide, gamma radiation, e-beam radiation, ultraviolet radiation, steam,plasma, or hydrogen peroxide. In some embodiments, the needle issterilized prior to installing the needle cover. In some embodiments,the needle is sterilized after the needle cover is installed. Forexample, in some embodiments, the needle cover is installed and then agas sterilant is conveyed through at least a portion of the needlecover. The needle is sterilized using a gas sterilization technique thatcan penetrate one or more pores of a porous needle cover. In someembodiments, the needle can be sterilized using a gas sterilizationtechnique that can penetrate one or more pores of a porous needle cover,but that will not react with a medicament in a medicament containerdisposed in the housing.

An electronic circuit system is then coupled to the housing of theassembled medical device, 106. The electronic circuit system is coupledto the housing such that an opening defined by a substrate of theelectronic circuit system is disposed about a portion of the safetylock. The electronic circuit system is configured to output anelectronic output in response to a movement of the safety lock withinthe opening. In some embodiments, for example, the electronic circuitsystem can be similar to the electronic circuit system 4900 of themedical injector 4000 and/or the electronic circuit system 5900 of themedicament delivery device 5000, as described above. In someembodiments, the electronic output can be, for example, a visual output,an audible output, and/or a haptic output, such as those describedabove. In other embodiments, the electronic output can be a wirelesssignal configured to be received by a remote device.

After the electronic circuit system is coupled to the housing, a covercan optionally be disposed about the medical device, 108. The cover canhave a protrusion disposed between a battery and a battery contactportion of the electronic circuit system. In some embodiments, forexample, the cover can be similar to the cover 4200 of the medicalinjector 4000 and/or the cover 5200 of the medical injector 5000.

FIG. 42 is a flow chart of a method 120 according to an embodiment ofthe invention. The method includes optionally assembling a simulatedmedicament delivery device, 122. The medicament delivery device caninclude a housing, an actuator and a safety lock. The simulatedmedicament delivery device is configured to simulate an actualmedicament delivery device. An electronic circuit system is then alignedwith a portion of the housing configured to receive the electroniccircuit system, 124. Aligning the electronic circuit system with thehousing ensures that portions of the housing align with correspondingportions of the electronic circuit system. If the corresponding portionsdo not align, a number of issues can arise. For example, the electroniccircuit system may not function correctly and/or the electronic circuitsystem may be damaged as a result of improper alignment.

The electronic circuit system is then coupled to the simulatedmedicament delivery device such that a portion of the housing actuates aswitch of the electronic circuit system, 126. The electronic circuitsystem is configured to output an electronic output associated with ause of the simulated medicament delivery device and a state of theswitch. The switch can be similar to the electronic circuit systemconfiguration switch 5974 of the medicament delivery device 5000. Forexample, the electronic circuit system can output a first electronicoutput associated with a use of the simulated medicament delivery devicewhen the switch is in a first state and a second electronic outputassociated with a use of the simulated medicament delivery device whenthe switch is in a second state. In some embodiments, the electronicoutput can be, for example, a visual output, an audible output, and/or ahaptic output, such as those described above. In other embodiments, theelectronic output can be a wireless signal configured to be received bya remote device. As described above, any number of switches can bedisposed on the electronic circuit system.

In some embodiments, an electronic self-test can be used to verify theintegrity of an electronic circuit system and/or the switches of amedicament delivery device. FIG. 43 is a flow chart of a self-testmethod 150 that can be administered to ensure that a switch of theelectronic circuit system is in the proper state (i.e., a state thatcorresponds to the configuration of the medicament delivery device). Forexample, in some embodiments the method 150 can ensure that theelectronic circuit system configuration switch is in the correct state(i.e., a first state if the medicament delivery device is an actualmedicament delivery device or a second state if the medicament deliverydevice is a simulated medicament delivery device). The method includesapplying power to the battery terminals, 152 and thus the electroniccircuit system. If the electronic circuit system configuration switch isin the first state, 154, the electronic circuit system will output afirst output sequence, 155. For example, the first output sequence canconsist of the LEDs blinking in a first predetermined sequence (e.g.,green—red—green) followed by an audible output. The first outputsequence can indicate that the medicament delivery device is an actualmedicament delivery device and not a simulated medicament deliverydevice. If the electronic circuit system configuration switch is in thesecond state, 156, the electronic circuit system will output a secondoutput sequence, different than the first, 157. For example, the secondoutput sequence can consist of the LEDs blinking in a secondpredetermined sequence (e.g., red—green—green) followed by an audibleoutput. The second output sequence can indicate that the medicamentdelivery device is a trainer. If neither the first output sequence northe second output sequence occurs, the medical injector has failed thetest, 158, indicating that an error exists within the electronic circuitsystem.

In other embodiments, different electronic output sequences can be usedto indicate and/or test different modes of the medical injector. Forexample, the LEDs could blink in a third sequence to indicate a Spanishmedical injector. Additionally, any number of self tests can be used todetermine the state of each switch of the electronic circuit system.Further, the integrity of any number of electronic components of themedicament delivery device can be tested by the self-test. For example,the integrity of the LEDs and/or audio output device can be tested usinga similar self-test as the one described above.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, in some embodiments, the sidewall of the housing of amedicament delivery device can be rigid. In other embodiments, thesidewall can be a movable member such as, for example, a piston. In yetother embodiments, the sidewall can be a flexible member such as, forexample, a diaphragm. In some embodiments, the sidewall can betransparent allowing light to pass from a first region to a secondregion and vice versa. A transparent sidewall can be used in conjunctionwith an optical sensor. The sidewall can be integrally formed with thehousing or can be separately formed.

In other embodiments, the medicament container can be substantiallycylindrical with a substantially round and/or substantially ellipticalcross-sectional shape. Thus, the medicament container can define alongitudinal axis, the longitudinal axes of the medicament container canbe parallel, non-coaxial, and/or co-planar. The longitudinal axis of themedicament container can be co-axial with a longitudinal axis of thepiston portion of a movable member 4530. In still other embodiments, amedicament delivery device can contain multiple medicament containersand thus, multiple doses of medicament.

Although medical devices having two LEDs and an audio output device havebeen shown, in other embodiments the medical device might have anynumber of LEDs and/or audio output devices. Additionally, other types ofoutput devices, such as haptic output devices, can be used.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, electrical circuit system4900 can include an electronic circuit system configuration switchsimilar to that of electrical circuit system 5900.

What is claimed is:
 1. An apparatus comprising: a medicament deliverydevice configured to deliver a medicament, the medicament deliverydevice including a first housing and a medicament container, a distalend portion of the medicament container including a delivery memberthrough which the medicament is conveyed, a side wall of the firsthousing defining an interior volume within which the distal end portionof the medicament container is movably disposed; a second housing formedseparately from the first housing, the second housing including aconnection portion configured to be matingly coupled to a correspondingportion of the medicament delivery device; and an electronic circuitsystem including a switch, a light output device and a wireless networkinterface device, the electronic circuit system configured to produce alight output via the light output device when the switch is changed froma first state to a second state, the electronic circuit systemconfigured to receive an actuation signal associated with the actuationof the medicament delivery device, the electronic circuit systemconfigured to output, via the wireless network interface device, awireless signal associated with the actuation signal.
 2. The apparatusof 1, wherein the medicament delivery device is any one of a peninjector, an auto-injector, or an inhaler.
 3. A method, including:aligning an electronic circuit system with a medicament delivery device,the medicament delivery device including a first housing and amedicament container, a distal end portion of the medicament containerincluding a delivery member through which a medicament is conveyed, aside wall of the first housing defining an interior volume within whichthe distal end portion of the medicament container is movably disposed,the electronic circuit system coupled to a second housing, theelectronic circuit system including a switch, a light output device anda wireless network interface device, the electronic circuit systemconfigured to produce an electronic output via one of the light outputdevice or the wireless network interface device when the switch ischanged from a first state to a second state; and coupling the secondhousing to the medicament delivery device such that a connection portionof the medicament delivery device changes the switch from the firststate to the second state.
 4. The method of 3, wherein the medicamentdelivery device is any one of a pen injector, an auto-injector, or aninhaler.
 5. An apparatus, comprising: a simulated medicament deliverydevice configured to simulate an operation of an actual medicamentdelivery device, the simulated medicament delivery device being devoidof at least one of a medicament or a needle, the simulated medicamentdelivery device including a first housing defining an opening; and asecond housing formed separately from the first housing, the secondhousing including a connection portion configured to be matingly coupledto a corresponding portion of the simulated medicament delivery device;and an electronic circuit system including a switch, a light outputdevice and a wireless network interface device, the electronic circuitsystem configured to produce a light output via the light output devicewhen the switch is changed from a first state to a second state, theelectronic circuit system configured to receive an actuation signalassociated with the actuation of the simulated medicament deliverydevice, the electronic circuit system configured to output, via thewireless network interface device, a wireless signal associated with theactuation signal.
 6. The apparatus of claim 5, wherein: the firsthousing defines a status aperture; and the simulated medicament deliverydevice includes a status indicator visible through the status aperture,the status indicator configured to display a visual indicia to simulatea status indicator of the actual medicament delivery device.